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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS050506 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
The purpose of this study is to compare two different treatments to improve walking after stroke (or post-stroke).
The impact of stroke on walking is significant, with only 37 percent of stroke survivors able to walk after the first week after stroke (or post-stroke). Even among those who achieve independent ambulation, significant residual deficits persist in balance and gait speed with a 73 percent incidence of falls among individuals with mild to moderate impairment 6 months post-stroke. Body weight supported treadmill training is one therapeutic method for locomotor training that is rapidly being adopted into physical rehabilitation to improve walking after stroke.
The purpose of this multi-center, randomized controlled study is to compare two different treatments to improve walking after stroke. The two treatments are: 1) a training program that includes use of a body weight support system and a treadmill to practice walking and 2) a physical therapist monitored exercise program to work on general conditioning and strengthening in the patient's home. In addition, investigators will determine the best time to provide training after a stroke and if the training is beneficial for mild, moderate, or severe cases of stroke.
Four hundred subjects will be recruited from five facilities in Florida and California. Screening and subject recruitment will take place within 45 days post-stroke. All stroke patients will be screened to determine eligibility for the study. Eligible subjects will be followed for 2 months post-stroke. At that time, those who are eligible for enrollment and who consent to participate will undergo an exercise tolerance test and baseline assessment. Following this evaluation, participants will be randomized into one of three groups, according to the severity of their locomotor impairment: early locomotor, late locomotor, or early home exercise.
The early locomotor training group will begin the locomotor training program immediately (2 months post stroke). The locomotor training program is an out-patient program of locomotor training for 36 sessions, 3 times per week, using a body weight support system and stepping on a treadmill. The late locomotor training group will begin locomotor training at 6 months post-stroke. Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning immediately (2 months post stroke).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Locomotor Training Program | Active Comparator | body weight supported training program with treadmill |
|
| Late Locomotor Training Program | Active Comparator | body weight supported training program with treadmill |
|
| Early Home Exercise Program | Active Comparator | a non-specific low intensity exercise program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early locomotor training program | Behavioral | The early locomotor training program is an out-patient program of locomotor training for 36 sessions, 3 times per week, using a body weight support system and stepping on a treadmill and overground training beginning at 2 months post-stroke. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke | Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk. | 12 months post-stroke |
| Walking Speed: Measured During a 10-meter Walk | Baseline and 12 months post-stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke | Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk. | Baseline and 6 months post-stroke |
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Inclusion Criteria:
Exclusion Criteria:
Inclusion and exclusion criteria will be determined by a chart review, depression screen and subject interview by study physician or study coordinator. After initial chart and subject interview, each subject's treating physician will be asked to review inclusion and exclusion criteria and provide a letter supporting inclusion in the study. All subjects who meet selection criteria must successfully complete an exercise tolerance test
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| Name | Affiliation | Role |
|---|---|---|
| Pamela W. Duncan, PhD, PT, FAPTA, FAHA | Professor and Bette Busch Maniscalco, Doctor of Physical Therapy Division, Research Fellow, Department of Community and Family Medicine, Duke Center for Clinical Health Policy Research | Principal Investigator |
| Katherine J. Sullivan, Ph.D., PT | Co-Principal Investigator, Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California | Principal Investigator |
| Andrea L. Behrman, Ph.D., PT | Co-Principal Investigator, Department of Physical Therapy, Brooks Center for Rehabilitation Studies, University of Florida, and Department of Veteran Affairs Brain Rehabilitation Research Center, Gainesville, Florida | Principal Investigator |
| Stanley P. Azen, Ph.D., | Director Data Management Core, Biostatistics Division, Department of Preventive Medicine, University of Southern California, Los Angeles, California | Study Director |
| Samuel S. Wu, Ph.D. | Lead Biostatistician - Investigator, Department of Epidemiology and Health Policy Research, University of Florida | Study Director |
| Bruce H. Dobkin, MD | Investigator, Department of Neurology, University of California, Los Angeles, California | Study Director |
| Stephen E. Nadeau, MD | Investigator, Geriatric Research, Education and Clinical Center and the Brain Rehabilitation Research Center, Gainesville VA Medical Center, and the Department of Neurology, University of Florida College of Medicine, Gainesville, Fl |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centinela Freeman Memorial Hospital | Inglewood | California | United States | |||
| Long Beach Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39113593 | Derived | Seamon BA, Kautz SA, Velozo CA. Computerized Adaptive Testing for the Berg Balance Scale Improves Measurement Efficiency Without Compromising Precision in People With Stroke. Phys Ther. 2024 Nov 1;104(11):pzae112. doi: 10.1093/ptj/pzae112. | |
| 33481989 | Derived | Seamon BA, Kautz SA, Velozo CA. Measurement Precision and Efficiency of Computerized Adaptive Testing for the Activities-specific Balance Confidence Scale in People With Stroke. Phys Ther. 2021 Apr 4;101(4):pzab020. doi: 10.1093/ptj/pzab020. |
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Participants admitted for inpatient rehabilitation were screened by chart review. Eligible participants with first-time stroke received a comprehensive medical record review and physical and cognitive screening. At 2-months, those who maintained eligibility and successfully completed an exercise tolerance test were enrolled.
Participants were recruited from 6 inpatient rehabilitation centers in California and Florida from April 2006 through June 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Locomotor Training Program | Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke. |
| FG001 | Late Locomotor Training Program | Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke. |
| FG002 | Home Exercise Program | Home Exercise Program (HEP) was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Locomotor Training Program | Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke. |
| BG001 | Late Locomotor Training Program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke | Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk. | Intention to treat analysis. Missing data were imputed using the LOCF method. | Posted | Number | percent of participants | 12 months post-stroke |
|
Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early Locomotor Training Program | Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrent Stroke | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor fall, no or minimal injury | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela W. Duncan, PT, PhD, FAHA, FAPTA | Duke University | 919-681-2060 | pamela.duncan@duke.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
|
| Late locomotor training program | Behavioral | The late locomotor training program is an out-patient program of locomotor training for 36 sessions, 3 times per week, using a body weight support system and stepping on a treadmill and overground training beginning at 6 months post-stroke. |
|
|
| Home Exercise Program | Behavioral | Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning at 2 months post stroke. |
|
|
| 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk |
| Baseline and 6 months post-stroke |
| 6 Minute Walking Distance (Meters) | Distance walked in 6 minutes. | Baseline, 6 months and 12 months post-stroke |
| Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day | As measured with a step activity monitor averaged over 2 days. | Baseline, 6 months and 12 months post-stroke |
| Stroke Impact Scale (SIS) - Participation | Range = 0 - 100. The Stroke Impact Scale is a measure of function (including ADL-IADL and mobility) and quality of life (participation). The Participation Scale is a single domain of the Stroke Impact Scale in which participation is defined as the ability to engage in meaningful activities with 0 indicating inability to engage in any meaningful activities and 100 indicating the ability to fully engage in meaningful activities. | Baseline, 6 months and 12 months post-stroke |
| Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) | Range 0 - 100 The Stroke Impact Scale (SIS) is a measure of function including ADL/IADL. The ADL/IADL scale is a single domain of the Stroke Impact Scale in which ADL is defined as the ability to take care of basic needs and IADL is defined as the ability to perform activities that make it possible to live independently in the community, with 0 indicating complete dependence on others and 100 indicating the ability to live independently without difficulty. | Baseline, 6 months and 12 months post-stroke |
| Stroke Impact Scale (SIS) - Mobility | Range = 0 - 100. The Stroke Impact Scale (SIS) is a measure of function including Mobility. The Mobility scale is a single domain of the Stroke Impact Scale which captures the ability to balance and move, with 0 indicating severe restrictions in balance and mobility and 100 indicating independence in mobility and balance. | Baseline, 6 months and 12 months post-stroke |
| Fugl-Meyer Lower Extremity Score | Range 0 - 34 The Fugl-Meyer Lower Extremity Score measures your ability to move the lower extremity with 0 indicating no movement and 34 indicating the ability to selectively move the lower extremity without difficulty. | Baseline, 6 months and 12 months post-stroke |
| Berg Balance Score | Range = 0 - 56 The Berg Balance Score assesses balance in sitting, standing, reaching, shifting weight and turning, with 0 defined as inability to balance and 56 defined as the ability to balance independently and without difficulty while performing each task. | Baseline, 6 months and 12 months post-stroke |
| Activities Specific Balance Confidence (ABC) Score | Range = 0 - 100 The ABC scale is a self reported measure of confidence with activities such as walking around the house, standing on a chair to reach or getting out of a car without losing balance or becoming unsteady. A score of 0 indicates no confidence that the activities can be performed without losing balance and a score 100 indicates confidence that the activities can be accomplished without losing balance. | Baseline, 6 months and 12 months post-stroke |
| Study Director |
| Long Beach |
| California |
| United States |
| University of Southern California - PT Associates | Los Angeles | California | United States |
| Sharp Memorial Rehabilitation Center | San Diego | California | United States |
| University of Florida | Gainesville | Florida | United States |
| Brooks Rehabilitation Hospital | Jacksonville | Florida | United States |
| Florida Hospital | Orlando | Florida | United States |
| Duke University (Administrative Coordinating Center) | Durham | North Carolina | United States |
| 26498434 | Derived | Nadeau SE, Dobkin B, Wu SS, Pei Q, Duncan PW; LEAPS Investigative Team. The Effects of Stroke Type, Locus, and Extent on Long-Term Outcome of Gait Rehabilitation: The LEAPS Experience. Neurorehabil Neural Repair. 2016 Aug;30(7):615-25. doi: 10.1177/1545968315613851. Epub 2015 Oct 23. |
| 23504552 | Derived | Nadeau SE, Wu SS, Dobkin BH, Azen SP, Rose DK, Tilson JK, Cen SY, Duncan PW; LEAPS Investigative Team. Effects of task-specific and impairment-based training compared with usual care on functional walking ability after inpatient stroke rehabilitation: LEAPS Trial. Neurorehabil Neural Repair. 2013 May;27(4):370-80. doi: 10.1177/1545968313481284. Epub 2013 Mar 15. |
| 22246687 | Derived | Tilson JK, Wu SS, Cen SY, Feng Q, Rose DR, Behrman AL, Azen SP, Duncan PW. Characterizing and identifying risk for falls in the LEAPS study: a randomized clinical trial of interventions to improve walking poststroke. Stroke. 2012 Feb;43(2):446-52. doi: 10.1161/STROKEAHA.111.636258. Epub 2012 Jan 12. |
| 21612471 | Derived | Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK, Cen S, Hayden SK; LEAPS Investigative Team. Body-weight-supported treadmill rehabilitation after stroke. N Engl J Med. 2011 May 26;364(21):2026-36. doi: 10.1056/NEJMoa1010790. |
| 17996052 | Derived | Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK; LEAPS Investigative Team. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. BMC Neurol. 2007 Nov 8;7:39. doi: 10.1186/1471-2377-7-39. |
| Lost to Follow-up |
|
| Administrative Error |
|
| Physician Decision |
|
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke. |
| BG002 | Home Exercise Program | HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Time since stroke to randomization - days | Mean | Standard Deviation | days |
|
| Side of involvement | Number | participants |
|
| Stroke Type | Based on CT/MRI overread by study neurologists. | Number | participants |
|
| Modified Rankin Scale | Global measure of stroke disability | Number | participants |
|
| Comorbidities | Number | participants |
|
| Mini Mental Status Exam | Higher Score is Better;Range = 0-30 | Mean | Standard Deviation | scores on a scale |
|
| Walking Speed (m/sec) | Comfortable walking speed assessed by 10 meter walk. | Number | participants |
|
| Comfortable walking speed (m/sec) | Assessed with 10 meter walk test. | Mean | Standard Deviation | m/sec |
|
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke. |
| OG002 | Home Exercise Program | HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke. |
|
|
|
| Primary | Walking Speed: Measured During a 10-meter Walk | Posted | Mean | Standard Deviation | m/sec | Baseline and 12 months post-stroke |
|
|
|
|
| Secondary | Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke | Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk. | Intention to treat analysis. Missing data were imputed using the Last Observation Carried Forward (LOCF) method. | Posted | Number | percent of participants | Baseline and 6 months post-stroke |
|
|
|
|
| Secondary | 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk | Posted | Mean | Standard Deviation | m/sec | Baseline and 6 months post-stroke |
|
|
|
|
| Secondary | 6 Minute Walking Distance (Meters) | Distance walked in 6 minutes. | Posted | Mean | Standard Deviation | meters | Baseline, 6 months and 12 months post-stroke |
|
|
|
|
| Secondary | Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day | As measured with a step activity monitor averaged over 2 days. | Posted | Median | Inter-Quartile Range | steps | Baseline, 6 months and 12 months post-stroke |
|
|
|
|
| Secondary | Stroke Impact Scale (SIS) - Participation | Range = 0 - 100. The Stroke Impact Scale is a measure of function (including ADL-IADL and mobility) and quality of life (participation). The Participation Scale is a single domain of the Stroke Impact Scale in which participation is defined as the ability to engage in meaningful activities with 0 indicating inability to engage in any meaningful activities and 100 indicating the ability to fully engage in meaningful activities. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months and 12 months post-stroke |
|
|
|
|
| Secondary | Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) | Range 0 - 100 The Stroke Impact Scale (SIS) is a measure of function including ADL/IADL. The ADL/IADL scale is a single domain of the Stroke Impact Scale in which ADL is defined as the ability to take care of basic needs and IADL is defined as the ability to perform activities that make it possible to live independently in the community, with 0 indicating complete dependence on others and 100 indicating the ability to live independently without difficulty. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months and 12 months post-stroke |
|
|
|
|
| Secondary | Stroke Impact Scale (SIS) - Mobility | Range = 0 - 100. The Stroke Impact Scale (SIS) is a measure of function including Mobility. The Mobility scale is a single domain of the Stroke Impact Scale which captures the ability to balance and move, with 0 indicating severe restrictions in balance and mobility and 100 indicating independence in mobility and balance. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months and 12 months post-stroke |
|
|
|
|
| Secondary | Fugl-Meyer Lower Extremity Score | Range 0 - 34 The Fugl-Meyer Lower Extremity Score measures your ability to move the lower extremity with 0 indicating no movement and 34 indicating the ability to selectively move the lower extremity without difficulty. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months and 12 months post-stroke |
|
|
|
|
| Secondary | Berg Balance Score | Range = 0 - 56 The Berg Balance Score assesses balance in sitting, standing, reaching, shifting weight and turning, with 0 defined as inability to balance and 56 defined as the ability to balance independently and without difficulty while performing each task. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months and 12 months post-stroke |
|
|
|
|
| Secondary | Activities Specific Balance Confidence (ABC) Score | Range = 0 - 100 The ABC scale is a self reported measure of confidence with activities such as walking around the house, standing on a chair to reach or getting out of a car without losing balance or becoming unsteady. A score of 0 indicates no confidence that the activities can be performed without losing balance and a score 100 indicates confidence that the activities can be accomplished without losing balance. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months and 12 months post-stroke |
|
|
|
|
| 51 |
| 139 |
| 100 |
| 139 |
| EG001 | Late Locomotor Training Program | Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke. | 59 | 143 | 101 | 143 |
| EG002 | Home Exercise Program | HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke. | 39 | 126 | 88 | 126 |
| Myocardial Infarction (MI) | Cardiac disorders | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hospitalization | General disorders | Systematic Assessment |
|
| Limitation in activities of daily living (ADL)>48hrs | General disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Open sore or blister, cuts | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Muscle soreness or pain that persists for more than 48 hours | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness/Fainting | General disorders | Systematic Assessment |
|
| Diaphoretic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Excessive hypertension during exercise that requires the intervention to be stopped for the day | Cardiac disorders | Systematic Assessment |
|
| Low blood pressure during exercise that requires intervention to be stopped for the day | Cardiac disorders | Systematic Assessment |
|
| DVT | Vascular disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
|
| No |
| Superiority or Other |
| Logistic regression was used to compare the proportion of participants who improved functional level of walking between HEP and Late-LTP (Usual Care) adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression). | Regression, Logistic | Pairwise comparisons were conducted: HEP versus Late-LTP, which had received only usual care in the 2- to 6-month post-stroke period. | 0.007 | Odds Ratio (OR) | 2.04 | 2-Sided | 95 | 1.22 | 3.42 | No | Superiority or Other |
|
| 6 month secondary analysis. Following the overall ANOVA test, pairwise comparison was conducted to assess differences in walking speed changes between HEP and late-LTP. | t-test, 2 sided | <.0001 | Bonferroni adjustment for multiple testing was used in the pair-wise comparisons of the secondary outcomes. A difference is claimed to be statistically significant when p<0.0014. | Mean Difference (Final Values) | 0.10 | 2-Sided | 95 | 0.05 | 0.14 | No | Superiority or Other |
|
| 12-month change from baseline |
|
6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons. |
| ANOVA |
Test differences across the three groups in change of 6 minute walking distance from baseline to 6-month post stroke. |
| <0.001 |
| 95 |
| No |
| Superiority or Other |
|
| 12-month change from Baseline |
|
|
6 month secondary analysis. The Kruskal-Wallis procedure was used to assess differences across the three groups in number of steps taken in the community. Wilcoxon signed rank tests were used to compare within-group improvements. |
| Kruskal-Wallis |
Test differences across the three groups in change of number of steps from baseline to 6-month post stroke. |
| 0.04 |
| 95 |
| No |
| Superiority or Other |
|
| 12 month change from Baseline |
|
6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons. |
| ANOVA |
Test differences across the three groups in change of SIS Participation from baseline to 6-month post stroke. |
| 0.06 |
| 95 |
| No |
| Superiority or Other |
|
| 12-month change from baseline |
|
6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons. |
| ANOVA |
Test differences across the three groups in change of SIS ADL/iADL from baseline to 6-month post stroke. |
| 0.03 |
| 95 |
| No |
| Superiority or Other |
|
| 12-month change from baseline |
|
6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons. |
| ANOVA |
Test differences across the three groups in change of SIS Mobility from baseline to 6-month post stroke. |
| <.0001 |
| 95 |
| No |
| Superiority or Other |
|
| 12-month change from Baseline |
|
6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons. |
| ANOVA |
Test differences across the three groups in change of FM-LE from baseline to 6-month post stroke. |
| 0.04 |
| 95 |
| No |
| Superiority or Other |
|
| 12-month change from Baseline |
|
6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons. |
| ANOVA |
Test differences across the three groups in change of Berg Balance Score from baseline to 6-month post stroke. |
| 0.001 |
| 95 |
| No |
| Superiority or Other |
|
| 12-month change from Baseline |
|
6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons. |
| ANOVA |
Test differences across the three groups in change of ABC score from baseline to 6-month post stroke. |
| <0.001 |
| 95 |
| No |
| Superiority or Other |